FDA Device recall Z-1611-2013
Pinnacle¿ Destination¿ Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve
- FDA Device
- Class II
- terminated
- Published 2013-07-03
On 2013-07-03 the FDA classified a Class II recall of Pinnacle¿ Destination¿ Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve by Terumo Medical, citing medical devices were incorrectly labeled with extended expiration dates.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1611-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-30 |
| Published | 2013-07-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Terumo Medical |
| Distribution | US |
Product
Pinnacle¿ Destination¿ Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a conduit to facilitate the introduction of interventional and diagnostic devices into the human vasculature.
Reason
Medical devices were incorrectly labeled with extended expiration dates.
Identifiers
| code_info | Lot MM27 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1611-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.